Selective Treatment of Oral Povorcitinib in Hidradenitis Suppurativa Long-Term Extension Study (STOP-HS LTE)

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Incyte Corp.

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Immune System Diseases [C20]

Trial duration

26 Jul 2024 → ongoing

Decision date (initial)

2024-05-21

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

Funding sources

Incyte Corporation

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety, Therapy, Efficacy

To evaluate the long-term safety of povorcitinib.

Secondary objectives 5

1. To further evaluate the long-term safety of povorcitinib.
2. To evaluate the long-term efficacy of povorcitinib.
3. To evaluate the long-term effect of povorcitinib in reducing the incidence of flares.
4. To evaluate the effect of povorcitinib on QoL.
5. To evaluate the effect of povorcitinib on lesion counts.

Conditions and MedDRA coding

Hidradenitis Suppurativa

Study design 2 periods

Regulatory references

Plan to share IPD

No

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 5

1. Ability to comprehend and willingness to sign a written ICF for the study.
2. Completed the 54-week treatment period of the originating parent study (INCB 54707-301 or INCB 54707-302) without safety concerns, per investigator's assessment.
3. Has demonstrated compliance, as assessed by the investigator, with the procedures described in the study Protocol of the originating parent study.
4. Agreement to use contraception, as per section 5.1.4 of the protocol.
5. Willing and able to comply with the study Protocol and procedures.

Exclusion criteria 8

1. Had been permanently discontinued from study treatment during the originating parent study.
2. Had any treatment-related Grade 3 or higher adverse event, or any treatment-related serious adverse event during the originating parent study that would, in the investigator's assessment, pose a significant risk to the participant's safety in this LTE study.
3. Had temporary study drug interruption at the final visit of the originating parent study and, in the opinion of the investigator, participation in this LTE study would pose an unacceptable risk to participant.
4. Any condition that, in the opinion of the investigator, renders the participant unable to understand the nature, scope, and possible consequences of the study or precludes the participant from following and completing the Protocol.
5. Women who are pregnant (or who are considering pregnancy) or breastfeeding.
6. Plans for administration of a live, attenuated vaccine during the course of the study or within 8 weeks after the last dose of study drug.
7. Any condition or laboratory result during the originating parent study that, in the investigator's and sponsor's (or designee's) judgment, may interfere with full participation in this LTE study, including administration of study drug and attending required study visits, may pose a significant risk to the participant, or may interfere with interpretation of study data.
8. The following participants are excluded in France: vulnerable populations according to article L.1121-6 of the French Public Health Code and adults under legal protection, or who are unable to express their consent per article L.1121-8 of the French Public Health Code, not affiliated to a social security per article L.1121-8-1 of the French Public Health Code.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Proportion of participants with treatment-emergent adverse events (TEAEs).

Secondary endpoints 15

1. Proportion of participants with serious TEAEs.
2. Proportion of participants with serious TEAEs leading to study drug discontinuation.
3. Proportion of participants who achieve HiSCR at each visit. − HiSCR is defined as at least a 50% reduction from baseline of parent study in the total AN count, with no increase from baseline of parent study in abscess or draining tunnel count.
4. Proportion of participants who achieve HiSCR75 at each visit. − HiSCR75 is defined as at least a 75% reduction from baseline of parent study in the total AN count, with no increase from baseline of parent study in abscess or draining tunnel count.
5. Proportion of participants who achieve HiSCR90 at each visit. − HiSCR90 is defined as at least a 90% reduction from baseline of parent study in the total AN count, with no increase from baseline of parent study in abscess or draining tunnel count.
6. Proportion of participants who achieve HiSCR100 at each visit. − HiSCR100 is defined as a 100% reduction from baseline of parent study in the total AN count, with no increase from baseline of parent study in abscess or draining tunnel count.
7. Proportion of participants with flare at each visit. − Flare is defined as at least a 25% increase in AN count with a minimum increase of 2 Ans relative to Week 54.
8. Time to first flare.
9. Mean change from baseline of parent study in HiSQoL score at each visit. − The HiSQoL is a 17-item, HS-specific, health-related QoL instrument with a 7‐day recall period. The HiSQoL total score ranges from 0 to 68, with higher scores indicating higher disease impact on QoL.
10. Mean change from baseline of parent study in DLQI at each visit. − The DLQI is a skin disease–specific questionnaire aimed at the evaluation of how the disease affects health-related QoL. The DLQI total score ranges from 0 to 30 with higher scores indicating higher skin disease impact on QoL.
11. Proportion of participants with no increase in AN count relative to Week 54 at each visit.
12. Proportion of participants with no increase in ANdT count relative to Week 54 at each visit. − ANdT count is defined as the total sum of abscess, inflammatory nodule, and draining tunnel.
13. Proportion of participants with no increase in draining tunnel count relative to Week 54 at each visit.
14. Proportion of participants with a total AN count of 0, 1, or 2 at each visit.
15. Proportion of participants with a total ANdT count of 0, 1, or 2 at each visit.

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 2

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Incyte Corp.

Sponsor organisation

Incyte Corp.

Address

1801 Augustine Cut Off

City

Wilmington

Postcode

19803-4404

Country

United States

Scientific contact point

Organisation

Incyte Corp.

Contact name

Clinical Trial Information

Public contact point

Organisation

Incyte Corp.

Contact name

Clinical Trial Information

Third parties 9

Locations

12 EU/EEA countries · 83 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 168 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

19 submissions — initial application plus substantial / non-substantial modifications